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Completed

NCT Number: NCT04234178

Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension in Labor Analgesia

Labor is the process where the cervix is prepared to allow the baby to pass from the uterine cavity to the outside world. In the ordinary course, it ends with spontaneous or instrumental vaginal delivery or cesarean section. Traditionally, the first stage in which the cervix is passively dilated in response to uterine contractions consists of the second stage in which the mother passes the baby through the vagina and the third stage, the exit of the placenta.

In the first stage of labor, pain is caused by uterine contractions and pressure on the cervix. Pain is transmitted through the T10-L2 spinal nerves and is felt in the abdominal wall, waist, hips, or thighs. In the second stage, pain from the vagina and perineum is added to uterine pain. This pain is transmitted by the pudendal nerves through the S2-4 nerve roots.

In this study, we aimed to investigate the effects of dural puncture epidural analgesia versus combined spinal-epidural analgesia with epidural volume extension on labor variables.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University, Erzurum, Yakutiye, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I and II parturients
  • Pregnant patients in active labor
  • active labor with cervical dilation < 5cm
  • 37-42 weeks of gestational age
  • Pregnant women between the ages of 18 and 45

Exclusion criteria

  • Patients who do not want to participate voluntarily in the study
  • Pregnant women outside the age range of 18 - 45
  • Pregnants other than Nullipar
  • Patients with allergic reactions to anesthesia and analgesia drugs to be used
  • Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
  • Gestational comorbidity (preeclampsia, eclampsia, diabetes mellitus, etc.)
  • Substance abuse history
  • Chronic pain history
  • Psychiatric problems and communication difficulties
  • BMI> 35 kg / m2
  • Failure in neuraxial interventions

Treatment and study plan

Epidural

Drug

2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural

Intrathecal+Epidural

Drug

10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural

Primary outcomes

  1. First Epidural top-up time

    Time frame: First 24 hours

    Time elapsed between the end of local anesthetic injection and the return of pain >4 on the NPRS.

Secondary outcomes

  1. Sacral analgesia time

    Time frame: First 24 hours

    Blockade of the S2 dermatome

  2. Performance time

    Time frame: First 24 hours

    interval between skin disinfection and epidural catheter fixation to the skin

  3. Incidence of Side Effect

    Time frame: First 24 hours

    maternal motor block, hypotension, pruritis, headache and fetal bradycardia

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effects of Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension Techniques on Birth Variables in Labor Analgesia

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 21, 2020
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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